Throughout the years the medical field has utilized various techniques in an effort to join or bond body tissue together. Historically, suturing was the accepted technique for rejoining severed tissues and closing wounds. Suturing was historically achieved with a surgical needle and a suturing thread, and more recently, with a variety of polymeric or metallic staples. The intended function of sutures is to hold the edges of a wound or tissue against one another during the healing process so as to reduce discomfort, pain, scarring and the time required for healing. Staples have recently been used to replace suturing when joining or anastomosing various body structures, such as, for example, the bowel. The surgical stapling devices employed to apply these staples are generally designed to simultaneously cut and seal an extended segment of tissue in a patient.
Linear or annular surgical stapling devices are employed by surgeons to sequentially or simultaneously apply one or more rows of surgical fasteners, e.g., staples or two-part fasteners, to body tissue for the purpose of joining segments of body tissue together and/or for the creation of an anastomosis. Linear surgical stapling devices generally include a pair of jaws or finger-like structures between which body tissue to be joined is placed. When the surgical stapling device is actuated and/or “fired,” firing bars move longitudinally and contact staple drive members in one of the jaws, and surgical staples are pushed through the body tissue and into and against an anvil in the opposite jaw thereby crimping the staples closed. A knife blade may be provided to cut between the rows/lines of staples.
Annular surgical stapling devices generally include an annular staple cartridge assembly including a plurality of annular rows of staples (typically two), an anvil assembly operatively associated with the annular cartridge assembly, and an annular blade disposed internal of the rows of staples. In general, an end-to-end anastomosis stapler typically places an array of staples into the approximated sections of a patient's bowels or other tubular organs. The resulting anastomosis contains an inverted section of bowel which contains numerous “B” shaped staples to maintain a secure connection between the approximated sections of bowel.
Anastomotic leaks may result in significant morbidity and frequently death. In addition to the use of surgical staples, sealants, e.g., synthetic or biological sealants, can be applied to the surgical site to guard against leakage. The biological sealants are typically applied to the outer surface of the anastomosis by using a dual lumen syringe or spray nozzle in a separate step. Still, the delivery of the sealant is compromised by an inability to get it at or between individual staple sites, and along staple lines and tissue seams. Typically, the biological sealants are manually applied to the outer surface of the staple line by a physician by spraying on, brushing on, swabbing on, or any combinations thereof. This manual application of biological sealant can lead to non-uniformity of the thickness of sealant across the staple line and/o omitting a portion of the intended coverage area due to inability to see or reach the desired location. In addition the manual application of the sealant is difficult to perform uniformly and efficiently, particularly because the sealants are designed to cure very quickly.
The biological sealants are known to be applied to the outer surface of the anastomosis by using a dual lumen syringe or spray nozzle in a separate step. The efficacy of fibrin sealant in prevention of leak after bariatric surgery has been shown in nonrandomized studies, as shown in the following references:
Liu C D, Glantz G J, Livingston E H. Fibrin glue as a sealant for high-risk anastomosis in surgery for morbid obesity. Obes Surg. 2003; 13:45-48.
Lee M G, Provost D A, Jones D B. Use of fibrin sealant in laparoscopic gastric bypass for the morbidly obese. Obes Surg. 2004; 14:1321-1326.
Papavramidis S T, Eleftheriadis E, Papavramidis T S, et al. Endoscopic management of gastrocutaneous fistula after bariatric surgery by using a fibrin sealant. Gastrointest Endosc. 2004; 59:296-300.
Garcia-Caballero M, Carbajo M, Martinez-Moreno J M, et al. Drain erosion and gastro-jejunal fistula after one-anastomosis gastric bypass: endoscopic occlusion by fibrin sealant. Obes Surg. 2005; 15:719-722.
Sapala J A, Wood M H, Schuhknecht M P. Anastomotic leak prophylaxis using a vapor-heated fibrin sealant: report on 738 gastric bypass patients. Obes. Surg. 2004; 14:35-42.
However, prospective, randomized, multicenter, clinical trials in laparoscopic bypass surgery (not lower anterior resection or sigmoidectomy) have shown that there was little difference in leak rates between fibrin glue and control groups, as shown in the below references:
Silecchia G, Boru C E, Mould J, et al. Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial, Obes Surg. 2006; 16:125-131.
Silecchia G, Boru C E, Mouiel J, et al. The use of fibrin sealant to prevent major complications following laparoscopic gastric bypass: results of a multicenter, randomized trial. Surg Endosc. 2008; 22:2492-2497.
One possible underlying reason for the poor performance of the sealant is that the delivery of the sealant is not optimized or is compromised by an inability to get it at or between individual staple sites, and along staple lines and tissue seams.
U.S. Pat. No. 8,281,975, entitled “Surgical apparatus and structure for applying sprayable wound treatment material” to Criscuolo and Bettuchi, discloses an apparatus for forming an anastomosis between adjacent sections of tissue. The apparatus includes a body portion; an actuation assembly operatively supported at a proximal end of the body portion; an anvil assembly movably mounted at the distal end of the body portion for movement toward and away from the body portion; an approximation assembly extending between the body portion and the anvil assembly for moving the anvil toward and away from the tubular body portion; a dispersion assembly operatively associated with the approximation assembly, the dispersion assembly including at least one angled surface defining at least one channel interposed between the anvil assembly and the body portion and being configured to dispense a fluid therefrom; and at least one conduit for conducting wound treatment material to the dispersion assembly.
The disadvantages of the Criscuolo apparatus relate to the conduit and the dispersion assembly being built into the body of the apparatus. Thus, the system can be clogged with tissue, blood, body fluids, and other matter during the installation of the apparatus within the intestine in preparation to the circular anastomosis, and thereby rendering the apparatus incapable of the delivery of the sealant as intended. Moreover, if the dispersion assembly exit nozzles became clogged by the rapidly curing sealant, for instance due to the minor delay or complication during the anastomotic procedure, the delivery of the sealant will be prevented with no recourse. In addition, the sterilization and cleaning of the apparatus becomes complicated once a rapidly curing sealant is introduced into the narrow channels and orifices of the conduit and the dispersion assembly. Further, the size of the dispersion assembly is fixed by the size of the approximation assembly on which it is formed and thus the dispersion assembly cannot be readily adjusted or adapted for different spraying pattern, spray coverage, and the like to accommodate different anatomy of the patient and different needs of the surgeon performing the anastomosis.
U.S. Pat. No. 8,152,042 discloses a number of embodiments for improving sealing at the anastomotic site. In some embodiments, a washer or structural body is wrapped completely around the anvil shaft, with staples driven through the structural body to release the sealant.
U.S. Pat. No. 7,972,357 to Bettuchi and entitled “Extraluminal sealant applicator and method” and U.S. Pat. No. 7,744,624 disclose apparatus for applying sealant to a target tissue of a surgical site. The apparatus includes a handle, a conduit and an end effector. The handle has means configured and adapted for operating the end effector and dispensing biological sealant to the surgical site via the end effector. The conduit stores and/or carries sealant towards the end effector. The end effector is configured to clamp around a body organ or tissue and apply and confine biological sealant in a substantially uniform manner. More specifically, the references disclose a system for applying sealant to a target tissue of a surgical site, comprising: a two-part sealant comprising a first part and a second part; an apparatus comprising: a handle; an end effector in operative association with the handle, the end effector including a first jaw member, a second jaw member, and a sealant-applying structure configured for applying sealant to the target tissue; the first jaw member being in fluid communication with a first conduit and a second conduit to convey sealant to the sealant-applying structure; the second jaw member being in fluid communication with a third conduit and a fourth conduit to convey sealant to the sealant-applying structure; the first and third conduits configured for conveying the first part of the two-part sealant to the sealant-applying structure; and the second and fourth conduits configured for conveying the second part of the two-part sealant to the sealant-applying structure. The Bettuchi apparatus is bulky and is only capable of applying the sealant on the outside and around the tissue joint, with additional difficulty in precisely targeting the application of the sealant.
U.S. Pat. No. 8,096,458 entitled “Pouch used to deliver medication when ruptured” describes a surgical stapling device, comprising: a handle portion; an elongate body portion; and a head portion located at the distal end of the body portion, the head portion including an anvil assembly, a staple cartridge assembly and a knife blade, the staple cartridge assembly having an annular array of staples, the anvil assembly being connected to the body portion along a shaft, the anvil assembly including: an anvil plate defining a plurality of staple forming pockets therein and a recess; and a wound treatment material disposed substantially within the recess.
U.S. Pat. No. 8,241,308 entitled “Tissue fastening devices and processes that promote tissue adhesion” discloses a fastener for fastening tissue segments having tissue surfaces, the fastener comprising: a first fastener member defining a fluid opening configured to receive a therapeutic agent, a plurality of fluid ports configured to deliver the therapeutic agent to the tissue segments, and a passageway between the fluid opening and the plurality of fluid ports; and a second fastener member having a substantially flat base and a post extending from the base proximate a center of the base, the post defining an opening for receiving and retaining the first fastener member such that the tissue segments to be fastened are retained between the first and second fastening members, the substantially flat base extending radially beyond a periphery of the post; wherein a longitudinal axis extends through the fluid opening, the fluid ports being radially arranged about the axis.